Examining how depression affects body temperature regulation

Thermoregulatory Responses to Heat Stress in Adults With Major Depressive Disorder With and Without Antidepressant Treatment

This study is trying to see how depression and its treatments affect how the body regulates temperature during heat stress in different groups of adults.

Quick facts

• Study type: Observational
• Enrollment: 64 (estimated)
• Ages: 18 Years to 40 Years
• Sex: All
• Sponsor: Penn State University (Academic / other)
• Locations: 1 site (University Park, Pennsylvania)
• Trial ID: NCT06805851 on ClinicalTrials.gov

What this trial studies

This observational study aims to investigate the differences in skin blood flow and sweating responses to passive heat stress among four groups: non-depressed adults, adults with major depressive disorder (MDD) not on medication, and adults with MDD who are taking either selective serotonin reuptake inhibitors (SSRIs) or serotonin norepinephrine reuptake inhibitors (SNRIs). Participants will undergo a passive heat stress experiment where their body temperature, skin blood flow, and sweat rates will be continuously monitored. The goal is to understand how depression and its treatments influence thermoregulation. All subjects will provide informed consent and complete a medical screening prior to participation.

Who should consider this trial

Good fit: Ideal candidates include adults aged 18-40 with or without major depressive disorder, including those currently treated with SSRIs or SNRIs.

Not a fit: Patients who are not within the age range of 18-40 or those with significant comorbid conditions affecting thermoregulation may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could enhance understanding of how depression and its treatments affect physiological responses, potentially leading to better management strategies for patients with depression.

How similar studies have performed: While the specific focus on thermoregulation in depressed patients is less common, related studies have shown varying impacts of depression on physiological responses, suggesting potential for meaningful insights.

Eligibility criteria

Inclusion Criteria:

* Non-depressed adults aged 18-40 years;
* OR adults aged 18-40 years with clinically diagnosed major depressive disorder according to DSM-V criteria not currently receiving antidepressant treatment;
* OR adults aged 18-40 years with clinically diagnosed major depressive disorder with at least 2 weeks of treatment with a selective serotonin reuptake inhibitor;
* OR aged 18-40 years adults with clinically diagnosed major depressive disorder with at least 2 weeks of treatment with a serotonin norepinephrine reuptake inhibitor;
* All participants will be asymptomatic and no signs/symptoms of disease according to the American College of Sports Medicine 10th edition Guidelines for Exercise Testing and Prescription (chest pain or pressure, dizziness, joint pain, and signs of cardiovascular disease);
* Systolic blood pressure 140 mmHg and diastolic pressure 90 mmHg at screening;
* Non-diabetic
* Not taking any other medications that might affect the physiological variables of interest (beta blockers, tricyclic antidepressants, antipyretics, diuretics, etc.);;
* Between the 20th and 80th percentiles for sex- and age-appropriate VO2max according to the American College of Sports Medicine 10th edition Guidelines for Exercise Testing and Prescription;
* English proficiency;
* Capable of providing informed consent.

Exclusion Criteria:

* BMI \> 35
* Are pregnant or planning to become pregnant in the next 12 months;
* Concurrently participate in another study involving physical activity or weight loss;
* Plan to have surgery or relocate outside the area within the next year;
* Medications that could alter cardiovascular or thermoregulatory responses to exercise (beta blockers, antipyretics, tricyclic antidepressants, diuretics, etc.);
* Allergy to latex or adhesive;
* Tobacco use;
* Illegal/recreational drug use;
* Exertional chest pain or musculoskeletal pain;
* Contraindications to a maximal exercise test or an indication for early termination of the exercise test according to the American College of Sports Medicine 10th edition Guidelines for Exercise Testing and Prescription;
* Abnormal resting or exercise electrocardiogram (ECG);
* Any bleeding disorders, gastric ulcers, allergies to NSAIDS, asthma, kidney/liver disorders, and taking any other anticoagulants;
* History of Crohn's disease, diverticulitis, or similar gastrointestinal disease;
* Co-morbid psychiatric disorders (psychosis, schizophrenia, bipolar disorder, panic disorder, obsessive compulsive disorder, etc.);
* Active suicidal ideation (moderate or high suicidality);
* Use of psychoactive or psychopharmacological drugs other than SSRI and SNRIs within one year of participating.

Where this trial is running

University Park, Pennsylvania

• Noll Laboratory — University Park, Pennsylvania, United States (Recruiting)

Study contacts

• Principal investigator: W. Larry Kenney — The Pennsylvania State University
• Study coordinator: W. Larry Kenney

Conditions Depression; Selective Serotonin Reuptake Inhibitor; thermoregulation; heat stress; depression; selective serotonin reuptake inhibitors; serotonin norepinephrine reuptake inhibitors